Transcutaneous Vagus Nerve Stimulation for the Treatment of Systemic Lupus Erythematosus
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- Aikaterini Thanou
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Percentage of Participants on Active vs Sham tVNS With Improvement in SLE Disease Activity by the BILAG-based Combined Lupus Assessment (BICLA)
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
This is a 3-month double blinded randomized controlled study of transcutaneous electrical vagus nerve stimulation (tVNS) compared to a sham stimulation for the treatment of patients with active systemic lupus erythematosus (SLE).
Detailed Description
Patients with SLE and active, non-organ-threatening disease are eligible to participate in this prospective randomized double blind trial of active or sham transcutaneous electrical vagus nerve stimulation (tVNS). Active tNVS is performed by the use of a transcutaneous electrical nerve stimulation (TENS) device with electrodes attached to an area of the external ear innervated by the auricular branch of the vagus nerve. The same protocol is followed in the sham tVNS arm, but the pads are placed on an area of the external ear that is devoid of vagus innervation.TENS is applied for 60 to 120 minutes daily as tolerated and participants keep a detailed log of their daily TENS sessions. Patients return to clinic at weeks 4, 8 and 12 for study related assessments.
Investigators
Aikaterini Thanou
Research Affiliate
Oklahoma Medical Research Foundation
Eligibility Criteria
Inclusion Criteria
- •Patients with SLE age 18-70 meeting the American College of Rheumatology Classification Criteria. Patients need to meet a minimum of 4 out of 11 criteria simultaneously or serially on two separate occasions.
- •Positive antinuclear antibody or anti-dsDNA within one year of screening
- •Non-serological SLEDAI ≥4 or ≥1 BILAG B or A and presence of inflammatory arthritis (defined by at least 3 swollen and 3 tender joints) at screening
- •Patients may receive on one or more of the following immune suppressive therapies: hydroxychloroquine, quinacrine, methotrexate, azathioprine, mycophenolate mofetil, tacrolimus, sirolimus, belimumab, abatacept. Immune suppressive medications should have been administered at stable doses for ≥30 days prior to baseline. Patients may also be on prednisone up to 10mg daily or equivalent steroid treatment at the baseline visit.
Exclusion Criteria
- •Acute lupus nephritis defined as class II,III, IV or V nephritis diagnosed within 6 months or prot/creat \> 1.5 gm/gm due to active lupus or in process of receiving induction therapy for nephritis
- •Active CNS lupus affecting mental status
- •Any other organ threatening or life threatening manifestation of SLE as well as those, who, in the opinion of the investigator, have severe multi-organ or refractory lupus
- •Rituximab treatment within 6 months prior to screening and/or without return of B cells to baseline levels
- •Treatment with cyclophosphamide within a month prior to screening
- •Treatment with any investigational drug within 3 months or 5 half-lives whichever is longer
- •Recurrent vaso-vagal syncopal episodes
- •Unilateral or bilateral vagotomy
- •Presence of any evidence of vagus nerve pathology or injury
- •Heart failure (NYHA class III or IV)
Outcomes
Primary Outcomes
Percentage of Participants on Active vs Sham tVNS With Improvement in SLE Disease Activity by the BILAG-based Combined Lupus Assessment (BICLA)
Time Frame: 12 weeks
Achieving a BICLA response requires to meet all of the following parameters: 1. All British Isles Lupus Assessment Group (BILAG) A scores improving to B/C/D and all BILAG level B scores improving to C/D 2. No single new BILAG A \& not \>1 new BILAG B scores, no worsening of the baseline Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score AND no worsening in the Physician Global Assessment (PGA) (\<10% worsening from baseline) 3. No initiation of non-protocol treatments or premature study discontinuation The range of values for the above instruments are listed below, with higher scores indicating more active disease: BILAG: 0 to 96 SLEDAI: 0 to 105 PGA: 0-3
Secondary Outcomes
- Percentage of Participants on Active vs Sham tVNS With Improvement in SLE Disease Activity by the Systemic Lupus Erythematosus Responder Index (SRI-4)(12 weeks)
- Percentage of Participants on Active vs Sham tVNS With Improvement in Heart Rate Variability (HRV)(12 weeks)